Following a public advisory committee meeting in May, the U.S. Food and Drug Administration (FDA) is requiring safety labeling changes to all opioid pain medications to better emphasize and explain the risks associated with their long-term use including misuse, addiction, and both fatal and non-fatal overdoses.
Labeling changes will include:
Clearer Risk Information: A summary of study results showing the estimated risks of addiction, misuse, and overdose during long-term use.
Dosing Warnings: Stronger warnings that higher doses come with greater risks, and that those risks remain over time.
Clarified Use Limits: Removing language that could be misinterpreted to support using opioid pain medications over a long duration
Treatment Guidance: Labels will reinforce that long-acting or extended-release opioids should only be considered when other treatments, including shorter-acting opioids, are inadequate.
Safe Discontinuation: A reminder not to stop opioids suddenly in patients who may be physically dependent, as it can cause serious harm.
Overdose Reversal Agents: Information on medicines that can reverse an opioid overdose.
Drug Interactions: Enhanced warning about combining opioids with other drugs that slow down the nervous system—now including gabapentinoids.
More Risks with Overdose: New information about toxic leukoencephalopathy—a serious brain condition that may occur after an overdose.
Digestive Health: Updates about opioid-related problems with the esophagus.
MyMatrixx by Evernorth Actions
MyMatrixx is dedicated to helping our clients monitor and manage the cost, utilization and safety of opioids and other pain medications within their claims and making sure our clients and the injured workers we serve are informed of the risks of opioids. If you have any questions, please reach out to your MyMatrixx account team.